Axonics Sacral Neuromodulation (SNM) System
FDA premarket approval P190006/S001 · decided 2020-01-14
Approval details
- PMA number
- P190006
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Axonics Sacral Neuromodulation (SNM) System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-10-15
- Decision date
- 2020-01-14
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for an updated software for the Axonics Clinician Programmer (CP), model 2501 (Software Version 416).
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